BradycardiaRADICAL USENCT04858698
Reduction Or Elimination Of Radiation During Implantation of Cardiac Devices Using Ultrasound
A study testing Ultrasound / Echocardiography in people with Bradycardia and Brady-tachy Syndrome, run by Habib Khan at 1 site in Canada.
Trial summary
Specialized equipment is required to put pacemakers in the heart. This requires use of radiation to see the wires or leads being implanted in the heart. Repeated radiation use can result in permanent injury to the patient and to the doctor. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bradycardia, Brady-tachy Syndrome
- What is being tested?
- Ultrasound / Echocardiography
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteCanada
- Study dates
- 30 Jul 2021to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18 years old.
- Suitable to have either a single chamber pacemaker or single chamber cardioverter-defibrillator.
Who cannot join
- BMI >30.
- Pregnancy.
- Implantation of dual-chamber and CRT devices.
- Claustrophobia.
- Tender chest wall or history of trauma to the chest wall.
- Higher signal interference using ultrasound due to the presence of other medical devices or tools used in previous surgical procedures such as sternal wires, mechanical valves, breast implants.
- History of radiation to the chest wall for oncology treatments.
- Active malignancy
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
London Health Sciences Centre Res. Inc. (Ont.)
London, Ontario, N6A 5A5
Habib I Khan, 5196633135, habib.khan@lhsc.on.ca
About this study
Official title: Reduction Or Elimination Of Radiation During Implantation of Cardiac Devices Using Ultrasound (RADICAl USe)
Specialized equipment is required to put pacemakers in the heart. This requires use of radiation to see the wires or leads being implanted in the heart. Repeated radiation use can result in permanent injury to the patient and to the doctor. The investigators aim to investigate if they can use ultrasound to guide and help in the implantation of leads into the heart. Ultrasound is a safe method and requires only a small handheld probe and a small screen to see different structures in the heart. If ultrasounds proves successful as a tool to reduce radiation then this would be very useful technical breakthrough. It would help develop smaller centres where pacemakers can be implanted without purchasing xray equipment and expensive setups.
Read the detailed description
Radiation quantity used in medicine is expanding year on year with increasing clinical uses for medical illnesses and to visualize instruments being used during procedures such as cardiac devices including pacemakers. The effects of radiation are not only on the patients for their procedure but also a cumulative effect of radiation on the operators. The stochastic effects of radiation have been well reported in the literature. Advancing technologies such as 3-dimensional(3D) mapping systems have allowed for leads to be identified using a 3D matrix and safely deployed to the myocardium. However, there are significant costs associated with the use of 3D mapping systems resulting in this approach not being widely adopted. Ultrasound use during implantation of cardiac implantable electronic devices (CIED) has been utilized in the past to gain vascular access via the axillary vein with good safety results. Experimental studies to visualize leads in the heart and venous systems using 3D ultrasound showed optimism but has not translated to clinical use due to lack of technology to improve the spatial and temporal resolution. The technology in imaging resolution has improved over the last 5 years and likely can be used to visualize a pacing lead in the heart. Techniques such as intravascular cardiac ultrasound have been used to assist in implanting lead via coronary sinus in individuals who can have contrast allergies. Therefore, transthoracic echocardiogram and ultrasound should be now of sufficient quality to allow for successful pacemaker insertion.
To date, there has not been a feasibility study to evaluate complete ultrasound and echocardiography-assisted pacemaker insertion.
In this study, the investigators aim to utilize ultrasound and echocardiography to gain vascular access and to direct the pacing lead into the right ventricle to allow for safe pacemaker implantation. If this is successful, then this will allow for a larger study to be conducted for single chamber devices including implantable cardioverter defibrillators. Moreover, the investigators will be able to analyze the cost-effectiveness of this new technique compared to the conventional technique of pacemaker implantation.
- Conditions
- Bradycardia, Brady-tachy Syndrome
- Being tested
- Ultrasound / Echocardiography
- Medical subject headings
- Bradycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound / EchocardiographyDevice
Also called Echocardiography by using St Jude - Zonaire ultrasound and P4-1c transducer.
Ultrasound will be used to guide vascular access and to place a lead into the right ventricle.
| Study group | Role | What they receive |
|---|---|---|
| Reduced fluoroscopy arm | Experimental | Patients exposed to 20 seconds or less of fluoroscopy to implant a single chamber device with aid of ultrasound / echocardiography. Receives: Device: Ultrasound / Echocardiography |
| Conventional arm | Active comparator | Patients exposed to more than 20 seconds of fluoroscopy to implant a single chamber device with/without the aid of ultrasound / echocardiography. Receives: Device: Ultrasound / Echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success of implanting a single chamber lead with use of ultrasound
Binary outcome - successful or not.
Measured: 0 day
Secondary outcomes (2)
Duration of radiation will be measured in seconds
Comparison between the treatment and control group
Measured: during procedure
Total radiation dose will be collected in centiGray and milliGray units.
Comparison between the treatment and control group
Measured: during procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2021
- Study start30 Jul 2021
- Primary completion30 Jun 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BradycardiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Habib Khan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Habib Khan, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04858698
- Sponsor's protocol ID
- 10510
- Acronym
- RADICAL USE
- Status last verified
- Feb 2024
- First submitted
- 8 Apr 2021
- Last updated
- 21 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Khan HR, Triemstra S, Pardo A, Moustafa AT, Mokhtar AT, Antiperovitch P, Saravu S, Mtwesi V, Gula LJ, Leong-Sit P, Manlucu J, Yee R, Tang A. Fluoroless Implantation of Pacemaker and Cardioverter-Defibrillator Using Ultrasound As An Imaging Tool: A Multi-Operator Experience in Radical Use Study. Can J Cardiol. 2026 Apr;42(4):750-756. doi: 10.1016/j.cjca.2025.11.052. Epub 2025 Dec 23.
PubMed 41448266
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction Or Elimination Of Radiation During Implantation of Cardiac Devices Using Ultrasound (RADICAl USe)
- ClinicalTrials.gov ID
- NCT04858698
- Acronym / sponsor ID
- RADICAL USE / 10510
- Conditions
- Bradycardia, Brady-tachy Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Habib KhanUniversity, hospital or other
- Study start
- 30 Jul 2021 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 26 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Specialized equipment is required to put pacemakers in the heart. This requires use of radiation to see the wires or leads being implanted in the heart. Repeated radiation use can result in permanent injury to the patient and to the doctor. The investigators aim to investigate if they can use ultrasound to guide and help in the implantation of leads into the heart. Ultrasound is a safe method and requires only a small handheld probe and a small screen to see different structures in the heart. If ultrasounds proves successful as a tool to reduce radiation then this would be very useful technical breakthrough. It would help develop smaller centres where pacemakers can be implanted without purchasing xray equipment and expensive setups.
Detailed description
Radiation quantity used in medicine is expanding year on year with increasing clinical uses for medical illnesses and to visualize instruments being used during procedures such as cardiac devices including pacemakers. The effects of radiation are not only on the patients for their procedure but also a cumulative effect of radiation on the operators. The stochastic effects of radiation have been well reported in the literature. Advancing technologies such as 3-dimensional(3D) mapping systems have allowed for leads to be identified using a 3D matrix and safely deployed to the myocardium. However, there are significant costs associated with the use of 3D mapping systems resulting in this approach not being widely adopted. Ultrasound use during implantation of cardiac implantable electronic devices (CIED) has been utilized in the past to gain vascular access via the axillary vein with good safety results. Experimental studies to visualize leads in the heart and venous systems using 3D ultrasound showed optimism but has not translated to clinical use due to lack of technology to improve the spatial and temporal resolution. The technology in imaging resolution has improved over the last 5 years and likely can be used to visualize a pacing lead in the heart. Techniques such as intravascular cardiac ultrasound have been used to assist in implanting lead via coronary sinus in individuals who can have contrast allergies. Therefore, transthoracic echocardiogram and ultrasound should be now of sufficient quality to allow for successful pacemaker insertion.
To date, there has not been a feasibility study to evaluate complete ultrasound and echocardiography-assisted pacemaker insertion.
In this study, the investigators aim to utilize ultrasound and echocardiography to gain vascular access and to direct the pacing lead into the right ventricle to allow for safe pacemaker implantation. If this is successful, then this will allow for a larger study to be conducted for single chamber devices including implantable cardioverter defibrillators. Moreover, the investigators will be able to analyze the cost-effectiveness of this new technique compared to the conventional technique of pacemaker implantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reduced fluoroscopy arm | Experimental | Device: Ultrasound / EchocardiographyPatients exposed to 20 seconds or less of fluoroscopy to implant a single chamber device with aid of ultrasound / echocardiography. |
| Conventional arm | Active comparator | Device: Ultrasound / EchocardiographyPatients exposed to more than 20 seconds of fluoroscopy to implant a single chamber device with/without the aid of ultrasound / echocardiography. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age >18 years old.
- Suitable to have either a single chamber pacemaker or single chamber cardioverter-defibrillator.
Key exclusion criteria (8 listed)
- BMI >30.
- Pregnancy.
- Implantation of dual-chamber and CRT devices.
- Claustrophobia.
- Tender chest wall or history of trauma to the chest wall.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound / EchocardiographyAlso: Echocardiography by using St Jude - Zonaire ultrasound and P4-1c transducer.Ultrasound will be used to guide vascular access and to place a lead into the right ventricle. | Device | Conventional arm, Reduced fluoroscopy arm |
Primary outcome
Success of implanting a single chamber lead with use of ultrasound
Time frame: 0 day
Binary outcome - successful or not.
2 secondary outcomes
Duration of radiation will be measured in seconds
Time frame: during procedure
Total radiation dose will be collected in centiGray and milliGray units.
Time frame: during procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2024.
- Derived from this study: PubMed 41448266Khan HR, Triemstra S, Pardo A, Moustafa AT, Mokhtar AT, Antiperovitch P, Saravu S, Mtwesi V, Gula LJ, Leong-Sit P, Manlucu J, Yee R, Tang A. Fluoroless Implantation of Pacemaker and Cardioverter-Defibrillator Using Ultrasound As An Imaging Tool: A Multi-Operator Experience in Radical Use Study. Can J Cardiol. 2026 Apr;42(4):750-756. doi: 10.1016/j.cjca.2025.11.052. Epub 2025 Dec 23.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound / Echocardiography in people with Bradycardia and Brady-tachy Syndrome, run by Habib Khan at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success of implanting a single chamber lead with use of ultrasound (time frame: 0 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04858698, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2024.